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Open, Classified

stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

FDA Recall Z-1466-2023 · Posted 2023-04-26

Recalling FirmWright Medical Technology, Inc.
Recall StatusOpen, Classified
Product CodeHRS
Date Initiated2023-04-10
Product Quantity41 units

Reason for Recall

Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.

Firm Action

The firm issued an URGENT: MEDICAL DEVICE RECALL notice to its sales representatives and distributors on 04/10/2023 by email and followed with letters disseminated to the remaining consignees via tracked FedEx mailing on Wednesday, April 12. The notice explained the issue and the risk and requested the following actions be taken: Identify all affected products and isolate/quarantine to prevent accidental use. All parties that further distributed the product were directed to notify anyone to the recipients of the affected products. The firm is seeking return of the products.

Root Cause

Employee error

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120359ORTHOLOC 3DI HALLUX SYSTEMWrightmedicaltechnologyinc · 2012-05-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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